RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. Interferon alfa may interfere with the growth of tumor cells. It is not yet known whether combination chemotherapy plus interleukin-2 and interferon alfa is more effective than combination chemotherapy alone for metastatic melanoma.

PURPOSE: Randomized phase III trial to compare combination chemotherapy with or without interleukin-2 and interferon alfa in treating patients who have metastatic melanoma that cannot be treated by surgery.

Compare response rate, duration of response, and survival rate in patients with metastatic malignant melanoma treated with cisplatin, vinblastine, and dacarbazine with or without interleukin-2 and interferon alfa-2b.

Determine the toxic effects of these regimens in this patient population.

OUTLINE: This is a randomized study. Patients are stratified according to performance status (0 vs 1), prior interferon (yes vs no), and number of involved sites. Patients are randomized to one of two treatment arms.

Arm I: Patients receive cisplatin IV over 30 minutes daily immediately followed by vinblastine IV on days 1-4. Patients also receive dacarbazine IV over 60 minutes on day 1 following vinblastine.

Arm II: Patients receive treatment as in arm I. Patients also receive interleukin 2 (IL-2) IV continuously on days 1-4 and interferon alfa-2b subcutaneously (SC) daily before IL-2 on days 1-4 and after IL-2 on day 5, followed by filgrastim (G-CSF) (SC) daily on days 7-16.

Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 6 weeks, every 3 months for 18 months, every 6 months for 18 months, and then annually for 2 years.

PROJECTED ACCRUAL: A total of 482 patients will be accrued for this study within 3.5 years.

SGOT less than 3 times the upper limit of normal unless due to liver metastases

Renal:

Creatinine less than 1.5 mg/dL OR

Creatinine clearance at least 75 mL/min

Cardiovascular:

No congestive heart failure

No symptoms of coronary artery disease

No serious cardiac arrhythmias

No prior myocardial infarction on EKG

Normal cardiac stress test required for the following:

Over 50 years of age

Abnormal EKG

Prior history of cardiac disease

Pulmonary:

No symptomatic pulmonary disease

FEV1 greater than 2.0 L OR at least 75% predicted if over 50 years of age or with history of pulmonary symptoms

Other:

Not pregnant or nursing

Negative pregnancy test

Fertile patients must use effective contraception

No significant infection

HIV negative

No other prior malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

No organ allografts

No significant disease other than malignancy

No seizure disorder

PRIOR CONCURRENT THERAPY:

Biologic therapy:

No prior interleukin-2 therapy for metastatic disease

At least 4 weeks since prior vaccine therapy

At least 4 weeks since prior adjuvant immunotherapy

Chemotherapy:

No prior chemotherapy for disease

Endocrine therapy:

No concurrent corticosteroids

Radiotherapy:

No prior radiation therapy to measurable disease site unless disease is clearly progressive

At least 4 weeks since prior radiation therapy for local control or palliation and recovered

Surgery:

Recovered from prior surgery

Other:

No prior systemic therapy for metastatic disease

At least 3 months since definitive therapy for brain metastases

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003027